Validation of Sterilization: Getting Started Is the Most Difficult Part

For steam sterilization, ethylene oxide (EO) sterilization, and even alternative methods like hydrogen peroxide, there are standards from the International Organization tor Standardization (ISO) for sterilization validation to guide a user through the actual validation process. The most important part of any validation is the beginning because it the initial work is not done properly, the rest of the validation is suspect. In the beginning ot a validation the first question to ask is: "What am I planning to validate and sterilize?"

If you have only one product and package combination, your answer is fairly simple and proceeding to the next step is not An issue. .Most of the lime, however, there are multiple products, packages, and types of sterilizer loads to be sterilized, especially with F( ) validations.

Your first challenge is to identify the "worst-case" location to sterilize. Is there only one difficult-to-sterilize location that can be identified from all the products? Are there multiple locations that could lie difficult to sterilize? Without data, how do you know where to place biological indicators (BI) to monitor tor validation? For example, a stent product may have multiple long dead end lumens of various small diameters and different lengths. F there any one location that is clearly the most difficult to sterilize of all the locations to lie sterilized? The answer must be known before you start any sterilizer validation. I have placed multiple BIs in one product and run fractional cycles to have test data when the answer was not clear.

Is there any one product clearly the most difficult to sterilize ot all the products to be sterilized? The answer is you may...